UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007415 |
|---|---|
| Receipt number | R000008735 |
| Scientific Title | Chemoradiation therapy after endoscopic resection for rectal carcinoma |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2021/09/08 08:21:23 |
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Basic information
Public title
Chemoradiation therapy after endoscopic resection for rectal carcinoma
Acronym
CRT after EMR for rectal carcinoma
Scientific Title
Chemoradiation therapy after endoscopic resection for rectal carcinoma
Scientific Title:Acronym
CRT after EMR for rectal carcinoma
Region
| Japan |
Condition
Condition
rectal carcinoma
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study of chemoradiation therapy after endoscopic resection for rectal carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
rate of recurrence and suuvival time
Key secondary outcomes
1)pathological findings of SM carcinoma
2)total dose of TS-1
3)total dose of radiation
4)site of recurrence, type of recurrence
5)survival rate, disease-free survival
6)adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We study alternate treatment for rectal cancer which was resected endoscopically.
TS-1 and radiation(total 45Gy) are replaced by the administration of surgical operation.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.rectal carcinoma(Rb)
2.lesion was resected by endoscopically.
3.indication of radical surgical resection
4.no metastasis in kickoff point
5.tolerable condition for chemoradiation
6.give informed consent
Key exclusion criteria
1.not satisfy selection criteria
2.drug allergy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Tomiki |
Organization
Juntendo University, Faculty of Medicine
Division name
Department of Coloproctological Surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo,113-8421, Japan
TEL
03-3813-3111
tomiki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Tomiki |
Organization
Juntendo University
Division name
Department of Coloproctological Surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL
03-3813-3111
Homepage URL
tomiki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University, Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo,113-8421, Japan
Tel
0338133111
tomiki@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 01 | Day |
Last modified on
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008735
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
